Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229613
Status:
RECRUITING
Last Update Posted:
2024-01-29
First Post:
2023-12-22
Brief Title:
Exhaled Breath Aerosol for the Etiological Diagnosis of Respiratory Tract Infections a Pilot Study
Sponsor:
Ospedale San Raffaele
Organization:
Ospedale San Raffaele
Study Overview
Official Title:
Exhaled Breath Aerosol for the Etiological Diagnosis of Respiratory Tract Infections a Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AEROPLEX
Brief Summary:
Pilot study for the evaluation of the feasibility of pathogen detection in exhaled breath aerosols XBAs samples using the AveloCollect device
The aim of the study is to evaluate the feasibility of XBA collection and molecular detection of respiratory pathogens using the AveloCollect BlowTube device index test in subjects with a clinical presentation consistent with a respiratory infectious disease compared to the same molecular assays performed on nasopharyngeal secretions using commercially available swabs and sputum comparator tests
The aim of the study is to evaluate the feasibility of XBA collection and molecular detection of respiratory pathogens using the AveloCollect BlowTube device index test in subjects with a clinical presentation consistent with a respiratory infectious disease compared to the same molecular assays performed on nasopharyngeal secretions using commercially available swabs and sputum comparator tests
Detailed Description:
Respiratory infections have a significant impact in terms of morbidity and mortality both in the EU and globally and were responsible for the majority of pandemics in the last centuries Human breath is an attractive sample type given the ease of sample collection via non-invasive methods its direct link to the route of transmission and its potential role as an indicator of infectiousness In particular recent studies have focused on the exhaled breath aerosols XBAs Aerosol transmission was demonstrated for many respiratory infections including pandemic influenza respiratory syncytial virus RSV tuberculosis TB and COVID-19 Pathogen detection in XBA samples has shown a good sensitivity but currently available research tools are highly technical and resource demanding New and simplified XBA collection devices Face masks AveloCollect Blow tube device are currently under evaluation and further clinical studies are needed in order to assess their feasibility for pathogen detection in clinical practice especially for etiological diagnosis in patients with unspecific respiratory symptoms
The objective of this study is to evaluate the feasibility of XBAs collection and analysis index test using the molecular tests currently in use at San Raffaele Hospital for the detection of respiratory pathogens in clinical samples compared to upper respiratory secretion and sputum samples that will be collected using standard procedures and analysed using the same kits comparator tests
The objective of this study is to evaluate the feasibility of XBAs collection and analysis index test using the molecular tests currently in use at San Raffaele Hospital for the detection of respiratory pathogens in clinical samples compared to upper respiratory secretion and sputum samples that will be collected using standard procedures and analysed using the same kits comparator tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None